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6 New FDA Orphan Drug Designations: Week of 06/01/15

June 7, 2015







The chart below identifies 6 new FDA Products Receiving Orphan Designation for the week of 06/01 – 06/05/15 as of 06/07/15 in ascending “Orphan Drug Designation Date” order.

FDA Products Receiving Orphan Drug Designation (Week of 06/01 – 06/05/15)

 # Generic Name/ODD Date Sponsor Company Indication
1 2-(5-fluoro-2-methyl-1H-indol-3-yl)-1H-imidazo[4,5-f][1,10] phenanthroline/ 06.01 Aptose Biosciences (Canada) Acute Myeloid Leukemia
2 17-a-hydroxyprogesterone caporate (oral formulation)/ 06.01 Lipocine Prevention of preterm birth in women with singleton pregnancy
3 Docosahexaenoic acid/ 06.01 Sancilio and Co Short Bowel Syndrome
4 Ibudilast/ 06.01 MediciNova Krabbe Disease
5 Immunologically active synthetic peptides/ 06.01 Apitope International NV (Belgium) Hemophilia A
6 Regorafenib/ 06.04 Bayer Hepatocellular carcinoma


** Generic Name/ODD Date” Column Link = Is the FDA Orphan Drug Product Designation Database Record.

Please Note : “Two small test tubes held in spring clamps” courtesy of  Amitchell125 at English Wikipedia [CC-BY-SA-30] | Wikimedia Commons.

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